Phytomenadione Injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

What is in this leaflet:

• What Phytomenadione Injection is and what it is used for
• What you need to know before you are given Phytomenadione Injection
• How Phytomenadione Injection is given
• Possible side effects
• How to store Phytomenadione Injection
• Contents of the pack and further information

1. What Phytomenadione Injection is and what it is used for

• This is a man-made vitamin called vitamin K1.
• Phytomenadione Injection is used for the following:
• To prevent and treat bleeding after the use of certain medicines to thin the blood (called anti-coagulants).
• To treat children (aged 1 year and older) who have liver disease or low levels of vitamin K in their body because of illness. Phytomenadione Injection is normally used to treat these children after advice from a specialist haematologist (blood doctor).
• Phytomenadione Injection works by helping your body make blood clotting factors. These blood clotting factors help stop bleeding.

2. What you need to know before you are given Phytomenadione Injection

You must not be given Phytomenadione Injection if you are allergic (hypersensitive) to phytomenadione or any of the other ingredients of Phytomenadione Injection (listed in Section 6: Further information).
If you are not sure if this applies to you, talk to your doctor or nurse before having Phytomenadione Injection.

Warnings and precautions

Check with your doctor or nurse before having Phytomenadione Injection if:

• You have severe problems with your liver.
• You have an artificial heart valve.

Other medicines and Phytomenadione Injection

Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes
medicines that you buy without a prescription and herbal medicines. This is because Phytomenadione Injection can
affect the way some medicines work. Also some other medicines may affect the way Phytomenadione Injection works.
In particular, tell your doctor or nurse if you are taking medicines to stop your blood clotting
(anticoagulants).

Pregnancy and breast-feeding

Talk to your doctor before having Phytomenadione Injection. if you are pregnant, think you are pregnant, or breastfeeding. Your doctor will then decide if you should receive Phytomenadione Injection.

Driving and using machines

Phytomenadione Injection is not likely to affect you being able to drive or use any tools or machines.
Talk to your doctor if you notice any problems that might affect driving, using tools or machines while having PhytomenadioneInjection.

Important information about some of the ingredients of Phytomenadione Injection

Phytomenadione Injection is essentially ‘sodium (a type of salt) free’ as it contains less than 1 ol sodium (2.64 mg per 1 ml).

3. How Phytomenadione Injection is given

Phytomenadione Injection will be given to you by a doctor or nurse. It will be given to you by injection into a vein or through a small tube into one of your veins (intravenous infusion).

Adults

• For people who are bleeding after taking blood-thinning (anticoagulant) medicines, the usual dose is 5 to10 mg.
• For people who have severe bleeding the Phytomenadione Injection dose (5 to 10 mg) is usually given with a blood transfusion.
• For people with mild bleeding or at risk of bleeding, the usual dose is 0.5 to 1 mg.
• If you need to have emergency surgery you may be given 5 mg PhytomenadioneInjection before surgery to reverse the effects of blood-thinning (anticoagulant) medicines.
• The maximum dose is usually no more than 40 mg PhytomenadioneInjection in 24 hours.
• Your doctor will usually check your blood for the levels of clotting factors, 3 hours after having Phytomenadione Injection and, if you need them give you more doses of Phytomenadione Injection

Elderly

Because elderly adults are sometimes more sensitive to Phytomenadione Injection your doctor may decide to start you on a lower dose. This dose may be increased or repeated if necessary. Children (aged 1 to 18 years) Phytomenadione Injection is normally used to treat children following advice from a specialist haematologist (blood doctor).

• The dose is usually no more than 5 mg.
• Some children may also need a blood transfusion.
• The doctor will usually check the child’s blood for the levels of clotting factors, 2 to 6 hours after they have Phytomenadione Injection and, if necessary, give more doses of Phytomenadione Injection.
• If you are given more Phytomenadione Injection than you should Because Phytomenadione Injection is given by a doctor or nurse, it is unlikely that you or your child will be given too much or that you or your child will miss a dose. However, if you are worried talk to your doctor or nurse.
• If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines Phytomenadione Injection may cause side effects, although not everyone will get them.
The following side effects may happen with this medicine:

• Allergic reactions The signs may include:
• Swelling of the throat, face, lips and mouth. This may make it difficult to breathe or swallow.
• Sudden swelling of the hands, feet and ankles.
• If you have an allergic reaction, tell a doctor straight away.

A reaction where the injection was given

• The signs may include swelling and redness along the vein where the medicine was given, which is very tender or painful when touched.
• Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
• By reporting side effects you can help provide more information on the safety of this medicine.

6. Contents of the pack and other information What Phytomenadione Injection contains

The active substance in Phytomenadione Injection Ampoules 1 mg/ml is vitamin K1 (phytomenadione).

• Each 1 ml of liquid medicine contains 1 mg vitamin K1.
• Other ingredients are glycocholic acid, sodium hydroxide, lecithin, hydrochloric acid and water for
  injections.
• What Phytomenadione Injection looks like and contents of the pack Phytomenadione Injection is a slightly opalescent, paleyellow liquid (‘solution forinfusion’Phytomenadione Injection is supplied in amber coloured glass ampoules in packs of 10.

5. How to store Phytomenadione Injection

• Your doctor or pharmacist is responsible for storing Phytomenadione Injection. They are also responsible for
• disposing of any unused Phytomenadione Injection correctly.
• Keep out of the sight and reach of children.
• Do not use Phytomenadione Injection after the expiry date printed on the pack.
• Phytomenadione Injection ampoules should be stored at a temperature below 25°C.